Orange Book product · Generic (ANDA)
PROGESTERONE
PROGESTERONE
At a glance
Sep 19, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 19, 2025
9 mo ago
Exclusivity ends · CGT
FDA marketing exclusivity
Mar 22, 2026
3 mo ago
Today
Pharmaceutical detail
Active ingredient
PROGESTERONE
Strength
100MG
Dosage form
INSERT
Route
VAGINAL
TE code
AB
Application
ANDA 218391
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PROGESTERONE
- 2020MILPROSABrand (NDA)
NDA 201110 · FERRING PHARMS INC
- 2007ENDOMETRINBrand (NDA)
NDA 022057 · FERRING
- 1998PROMETRIUMBrand (NDA)
NDA 019781 · ACERTIS PHARMS
- 1997CRINONEBrand (NDA)
NDA 020701 · ABBVIE
- —PROGESTERONEBrand (NDA)
NDA 017362 · ACTAVIS LABS UT INC
- —PROGESTERONEBrand (NDA)
NDA 009238 · LILLY
- —PROGESTASERTBrand (NDA)
NDA 017553 · ALZA
- 2026PROGESTERONEGeneric (ANDA)
ANDA 216363 · GLENMARK PHARMS
- 2023PROGESTERONEGeneric (ANDA)
ANDA 217707 · ACCORD HLTHCARE
- 2022PROGESTERONEGeneric (ANDA)
ANDA 215634 · XIROMED
- 2018PROGESTERONEGeneric (ANDA)
ANDA 210965 · EUGIA PHARMA
- 2018PROGESTERONEGeneric (ANDA)
ANDA 211285 · EUGIA PHARMA
Marketing exclusivity (1)
- CGTFDA marketing exclusivity
Mar 22, 2026
3 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
